ATE493972T1 - JOINTLY PROCESSED MICROCRYSTALLINE CELLULOSE AND SUGAR ALCOHOL AS AN EXCIPIENT FOR TABLET FORMULATIONS - Google Patents

JOINTLY PROCESSED MICROCRYSTALLINE CELLULOSE AND SUGAR ALCOHOL AS AN EXCIPIENT FOR TABLET FORMULATIONS

Info

Publication number
ATE493972T1
ATE493972T1 AT07852968T AT07852968T ATE493972T1 AT E493972 T1 ATE493972 T1 AT E493972T1 AT 07852968 T AT07852968 T AT 07852968T AT 07852968 T AT07852968 T AT 07852968T AT E493972 T1 ATE493972 T1 AT E493972T1
Authority
AT
Austria
Prior art keywords
sugar alcohol
microcrystalline cellulose
excipient
tablet formulations
jointly processed
Prior art date
Application number
AT07852968T
Other languages
German (de)
Inventor
Jian-Xin Li
Brian Carlin
Thomas Ruszkay
Original Assignee
Fmc Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fmc Corp filed Critical Fmc Corp
Application granted granted Critical
Publication of ATE493972T1 publication Critical patent/ATE493972T1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

A particulate co-processed composition comprising microcrystalline cellulose and at least one sugar alcohol is disclosed. A preferred sugar alcohol is mannitol. The composition has an improved compactability profile, lubricant sensitivity, and ejection profile compared to microcrystalline cellulose and the at least one sugar alcohol, either alone or in combination as a simple dry blend, in the preparation of solid dosage formulations, such as tablets. Tablets comprising the particulate co-processed composition, an active, and, optionally, one or more other excipients, and method for their preparation, are also disclosed.
AT07852968T 2006-10-27 2007-10-26 JOINTLY PROCESSED MICROCRYSTALLINE CELLULOSE AND SUGAR ALCOHOL AS AN EXCIPIENT FOR TABLET FORMULATIONS ATE493972T1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US85510606P 2006-10-27 2006-10-27
US85506606P 2006-10-27 2006-10-27
US92816607P 2007-05-08 2007-05-08
PCT/US2007/022685 WO2008057267A2 (en) 2006-10-27 2007-10-26 Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations

Publications (1)

Publication Number Publication Date
ATE493972T1 true ATE493972T1 (en) 2011-01-15

Family

ID=39317157

Family Applications (1)

Application Number Title Priority Date Filing Date
AT07852968T ATE493972T1 (en) 2006-10-27 2007-10-26 JOINTLY PROCESSED MICROCRYSTALLINE CELLULOSE AND SUGAR ALCOHOL AS AN EXCIPIENT FOR TABLET FORMULATIONS

Country Status (7)

Country Link
US (3) US7998505B2 (en)
EP (2) EP2076250B1 (en)
JP (2) JP2010507676A (en)
AT (1) ATE493972T1 (en)
DE (1) DE602007011792D1 (en)
TW (2) TW200826976A (en)
WO (2) WO2008057266A2 (en)

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WO2008057266A3 (en) 2008-11-13
TW200824721A (en) 2008-06-16
US8932629B2 (en) 2015-01-13
WO2008057267A2 (en) 2008-05-15
DE602007011792D1 (en) 2011-02-17
JP5410290B2 (en) 2014-02-05
JP2010507677A (en) 2010-03-11
JP2010507676A (en) 2010-03-11
US20080131505A1 (en) 2008-06-05
TW200826976A (en) 2008-07-01
EP2076249A2 (en) 2009-07-08
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US7998505B2 (en) 2011-08-16
EP2076250A2 (en) 2009-07-08

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